Home Applications 217504 Application 217504
Type ANDA
Sponsor MICRO LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML No No 002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTABLE;INJECTION EQ 5MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217504-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 A217504-002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217504-001 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217504-002 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2023-08-21 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midazolam MIDAZOLAM Micro Labs Limited 9221894f-d840-46f2-a11c-6b71358d3b5b 2023-08-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217504 application number: ANDA217504